RecruitingPhase 1NCT04329494
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)
Sponsor
City of Hope Medical Center
Enrollment
49 participants
Start Date
Aug 21, 2020
Study Type
INTERVENTIONAL
Conditions
Malignant Uterine NeoplasmPeritoneal CarcinomatosisClinical Stage IV Gastric Cancer AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Metastatic Malignant Solid NeoplasmStage IVA Uterine Corpus Cancer AJCC v8Stage IVB Uterine Corpus Cancer AJCC v8Metastatic Gastric CarcinomaMetastatic Ovarian CarcinomaStage IV Ovarian Cancer AJCC v8Metastatic Colorectal CarcinomaPostneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8Stage IV Uterine Corpus Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Metastatic Malignant Neoplasm in the PeritoneumPathologic Stage IV Gastric Cancer AJCC v8Metastatic Appendix CarcinomaStage IV Appendix Carcinoma AJCC v8Stage IVA Appendix Carcinoma AJCC v8Stage IVB Appendix Carcinoma AJCC v8Stage IVC Appendix Carcinoma AJCC v8
Summary
This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.
Eligibility
Min Age: 18 Years
Inclusion Criteria26
- Documented informed consent of the participant and/or legally authorized representative
- Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC
- Prior IP chemotherapy is permitted
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
- Absolute neutrophil count (ANC) \>= 1500/mm\^3
- Platelets \>= 100,000/mm\^3
- Hemoglobin \>= 9 g/dl
- Serum total bilirubin =\< 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 x ULN, unless liver metastases (Arm 1) are present or unless patients is know to have chronic liver disease (hepatitis) in which case AST and ALT must be =\< 5 x ULN
- Alkaline phosphatase =\< 2 x ULN
- Serum creatinine (sCr) =\< 1.5 x ULN, or creatinine clearance (Ccr) \>= 40 ml/min as calculated by the Cockcroft-Gault formula
- No contraindications for a laparoscopy
- The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to be visible on cross sectional imaging or diagnostic laparoscopy
- Patients must have progressed on at least one evidence-based chemotherapeutic regimen (Arm 1 and 2). For Arm 3, patients should have stable or responsive disease on at least 4 months first-line systemic chemotherapy
- For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is define as:
- Amenorrhea \>= 12 consecutive months without another cause or
- For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL
- Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
- INCLUSION TO PROCEED WITH PIPAC: Laparoscopy findings must meet all of the below criteria in order to proceed to PIPAC:
- PIPAC access is feasible
- There is room for aerosol therapy
- There is no evidence of impending bowel obstruction
- =\< 5 L of ascites
- Not a candidate for cytoreduction and HIPEC
Exclusion Criteria43
- Gastric and colorectal/appendiceal:
- Extra-peritoneal metastatic disease
- Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
- Arm 2 (colorectal/appendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency
- Arm 2 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition
- Arm 2 (colorectal/appendiceal): Prior unanticipated severe reaction or hypersensitivity to platinum based compounds
- Arm 2 (colorectal/appendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted
- Arm 2 (colorectal/appendiceal): Life expectancy of less than 6 months
- Arm 2 (colorectal/appendiceal): Chemotherapy or surgery within the last 4 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents
- Arm 2 (colorectal/appendiceal): Previous anaphylactic reaction to the chemotherapy drug used
- Arm 2 (colorectal/appendiceal): Patients may not be receiving any other investigational or concurrent anti-cancer agents
- Arm 2 (colorectal/appendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis
- Arm 2 (colorectal/appendiceal): Simultaneous tumor debulking with gastrointestinal resection
- Arm 2 (colorectal/appendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment
- Arm 2 (colorectal/appendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system
- Arm 2 (colorectal/appendiceal): Involvement in the planning and conduct of the study
- Arm 2 (colorectal/appendiceal): Pregnancy
- Arm 2 (colorectal/appendiceal): Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Arm 2 (colorectal/appendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months
- Arm 2 (colorectal/appendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug
- Arm 2 (colorectal/appendiceal): Exclusive total parenteral nutrition
- Arm 2 (colorectal/appendiceal): Prior intra-abdominal aerosol chemotherapy
- Arm 3 (colorectal/appendiceal): Progression on first- AND second-line systemic therapy
- Arm 3 (colorectal/appendiceal): Hematologic toxicities requiring significant dose reductions while on systemic chemotherapy
- Arm 3 (colorectal/appendiceal): Intolerance to prior 5-FU at 2400mg/m\^2 IV every 2 weeks or to irinotecan at 180mg/m\^2. Intolerance is defined as the need of significant dose reduction or treatment interruption of \> 1 week due to toxicity
- Arm 3 (colorectal/appendiceal): Known DPD deficiency
- Arm 3 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition
- Arm 3 (colorectal/appendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted
- Arm 3 (colorectal/appendiceal): Life expectancy of less than 6 months
- Arm 3 (colorectal/appendiceal): Chemotherapy or surgery within the last 2 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents
- Arm 3 (colorectal/appendiceal): Previous anaphylactic reaction to the chemotherapy drug used
- Arm 3 (colorectal/appendiceal): Patients may not be receiving any other investigational anti-cancer agents
- Arm 3 (colorectal/appendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis
- Arm 3 (colorectal/appendiceal): Simultaneous tumor debulking with gastrointestinal resection
- Arm 3 (colorectal/appendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment
- Arm 3 (colorectal/appendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system
- Arm 3 (colorectal/appendiceal): Involvement in the planning and conduct of the study
- Arm 3 (colorectal/appendiceal): Pregnancy
- Arm 3 (colorectal/appendiceal): Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Arm 3 (colorectal/appendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months
- Arm 3 (colorectal/appendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug
- Arm 3 (colorectal/appendiceal): Exclusive total parenteral nutrition
- Arm 3 (colorectal/appendiceal): Prior intra-abdominal aerosol chemotherapy
Interventions
PROCEDUREBiopsy
Undergo biopsy
DRUGCisplatin
Given via PIPAC
DRUGDoxorubicin
Given via PIPAC
DRUGFluorouracil
Given IV
DEVICEIntraperitoneal Chemotherapy
Undergo PIPAC
DRUGIrinotecan
Given IV
DRUGLeucovorin
Given IV
DRUGMitomycin
Given via PIPAC
DRUGOxaliplatin
Given via PIPAC
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT04329494
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